Safety and Efficacy Study in Acute Ischaemic Stroke (VASST)
Stroke
About this trial
This is an interventional treatment trial for Stroke focused on measuring Acute, Ischaemic, Stroke
Eligibility Criteria
Summary of Inclusion Criteria: Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment Aged 18 and above Provide consent Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive. NIHSS score greater than 5 or less than or equal to 20. Summary of Exclusion Criteria: Coma Stroke with unknown time of onset Minor stroke symptoms and sings (<6 points on the NIHSS) which are rapidly improving by the time of randomisation. Major stroke symptoms and signs (>20 on the NIHSS) History of stroke in previous 6 weeks History of brain tumours CT scan results in an ASPECT score of <5 Haemorrhagic risk Abnormal laboratory values Positive urine pregnancy test, lactation or parturition within previous 30 days. Weight >135 kg Uncontrolled hypertension. Raised blood glucose History of or current serious illness Participation in another clinical trial within 4 weeks of drug administration -
Sites / Locations
- Stroke Centre, Mayo Clinic
- UCLA Stroke Network
- Neurology Medical Group of Diablo Valley
- Bethesda Memorial Hospital
- Bradenton Research Centre
- Ocala Neurodiagnostic Centre
- Florida Hospital of Neuroscience Institute
- Tallahassee Memorial Hospital
- Florida Neurovascular Institue Stroke Center
- Vascular Neurology, Loyola University Medical Center
- Center for Advanced Medicine, Jewish Hospital
- University of Louisville Hospital
- UMAS Memorial Medical Centre
- Sunrise Hospital and Medical Centre
- Washoe Stroke Center
- Stroke Centre, Neurological Institute, Carolinas Medical Centre
- Forsyth Medical Center
- Lancaster General Hospital
- University of Pennsylvania Medical Center
- Medical University South Carolina Hospitals and Clinics
- Erlanger Health System
- Neurological Institute, The Methodist Hospital
- Division of Neuro-Ophthalmology, Virginia Commonwealth University
- Gordon & Leslie Diamond Health Care Centre
- Centre for Stroke Research, Vancouver Island Health Research Centre
- 71 King Street West
- Royal University Hospital
- Hospital Charles LeMoyne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
V10153, 1.0 mg/kg
V10153, 2.5 mg/kg
V10153, 5.0 mg/kg
V10153, 7.5 mg/kg
V10153, 10 mg/kg
Single acute intravenous bolus dose
Single acute intravenous bolus dose
Single acute intravenous bolus dose
Single acute intravenous bolus dose
Single acute intravenous bolus dose